A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

1. Able to understand and willing to sign the ICF.

2. Adults 18 years of age or older.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy at least 12 weeks.

5. Adequate organ and bone marrow function.

Eligibility Criteria：

1. Previous exposure to any anti-TIGIT antibody.

2. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.

3. Any investigational drugs received within 4 weeks prior to the first study treatment.

4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.

5. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.

6. Medication requiring long-term systemic hormones or any other immunosuppression therapy.

7. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.

8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.

9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases

10. Positive human immunodeficiency virus (HIV) test.

11. Active hepatitis B or C, or tuberculosis.

12. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

13. Known history of hypersensitivity to any components of the IBI939 or Sintilimab.

14. Pregnant or nursing females.